International Journal of Gynecology and Obstetrics xxx (2014) xxx–xxx

IJG-07968; No of Pages 5

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International Journal of Gynecology and Obstetrics

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CLINICAL ARTICLE

Abbreviated (12-hour) versus traditional (24-hour) postpartummagnesium sulfate therapy in severe pre-eclampsia

Sabina B. Maia a, Leila Katz a, Carlos Noronha Neto a, Bárbara V.R. Caiado b,Ana P.R.L. Azevedo a, Melania M.R. Amorim a,⁎a Instituto de Medicina Integral Professor Fernando Figueira, Recife, Brazilb Faculdade Pernambucana de Saúde, Recife, Brazil

⁎ Corresponding author at: Rua Neuza Borborema de So58406-120, Campina Grande, PB, Brazil. Tel.: +55 838822

E-mail address: melania.amorim@gmail.com (M.M.R.

http://dx.doi.org/10.1016/j.ijgo.2014.03.0240020-7292/© 2014 International Federation of Gynecology

Please cite this article as: Maia SB, et al, Asevere pre-eclampsia, Int J Gynecol Obstet

a b s t r a c t

a r t i c l e i n f o

Article history:

Received 7 September 2013Received in revised form 11 March 2014Accepted 30 April 2014

Keywords:Magnesium sulfate therapyPostpartumPre-eclampsia

Objective: To compare the use of magnesium sulfate for 12 hours versus 24 hours in postpartum women withstable severe pre-eclampsia.Methods: In 2011, an open randomized clinical trial was conducted with 120 post-partum women with severe pre-eclampsia who gave birth at a tertiary hospital in Brazil; 60 women receivedmagnesium sulfate for 24 hours and 60 for 12 hours. The analysis was by intention-to-treat and the interventionwas notmasked. Results:Abbreviated (12-hour)magnesium sulfate therapywas associatedwith less exposure tothe drug, and clinical outcomes were similar in both groups. No woman developed eclampsia and there was noneed to re-initiate treatment after completing the scheduledmagnesium sulfate therapy in either group. Magne-sium sulfate therapy was extended in only three women in the 12-hour group. In addition, in this group, signif-

icant reductions were found in the duration of postpartum use of an indwelling bladder catheter, the time toambulation, and the time to maternal contact with the newborn. Conclusion: Abbreviated postpartum magne-sium sulfate therapy in patientswith stable severe pre-eclampsiawas associatedwith less drug exposure, similaroutcomes, and benefits such as a reduction in the time to contact with the newborn.Clinical trials registration: clinicaltrials.gov NCT1408979 © 2014 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.

1. Introduction

Pre-eclampsia occurs in 8% of pregnancies [1–3]. An important com-plication is eclampsia,whichmay occur prior to, during, or following de-livery and is associated with an increased risk of maternal death [4–8].

Eclampsia can be prevented with magnesium sulfate, which de-creases the risk of seizures by 50%, paralleled by a reduction inmaternalmortality [6,9]. Although magnesium sulfate administration is recom-mended for all women with severe pre-eclampsia [1,9–11], consensushas yet to be reached on the ideal duration of prophylactic postpartumanticonvulsant therapy [9,12].

Traditionally, the use of magnesium sulfate has been recommendedfor 24 hours following delivery, the period of greatest risk for the occur-rence of eclampsia [1,13]. Nonrandomized studies have used clinicalcriteria for stopping magnesium sulfate earlier in some women withpre-eclampsia [14,15]. By reducing the duration of therapy, the frequen-cy of monitoring maternal blood pressure and urinary output may becurtailed and the possibility for the woman to ambulate and care forher newborn may be increased. However, a systematic review [16]

uza, 300, Bairro Santo Antônio,1514; fax: +55 8333424525.Amorim).

and Obstetrics. Published by Elsevier I

bbreviated (12-hour) versu(2014), http://dx.doi.org/10

found that some women who received a short-duration magnesiumtreatment regimen required a prolongation or re-institution of therapy,although this finding was not statistically significant.

In economically developing nations, the use of magnesium sulfate isalso effective [1]. However, unnecessarily prolonged use of magnesiumseizure prophylaxis in resource-constrained regions might delay amother’s return to normality and thus preclude such recommendedpractices as kangaroo care [17].

The present study was undertaken to compare the use of intrave-nous magnesium sulfate for 12 hours versus 24 hours postpartum onthe process of care for women with stable severe pre-eclampsia.

2. Materials and methods

The present study was an open-label, randomized clinical trial of12 hours versus 24 hours of intravenous magnesium sulfate adminis-tered immediately postpartum to women with stable severe pre-eclampsia. The study was conducted at the Instituto de Medicina Inte-gral Professor Fernando Figueira in Recife, Pernambuco, northeasternBrazil, between July 1 and October 31, 2011, and approved by the inter-nal Institutional Review Board.

Severe pre-eclampsia was defined as a systolic blood pressure of160 mm Hg or more and/or a diastolic blood pressure of 110 mm Hg

reland Ltd. All rights reserved.

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ormore, persisting at rest in the left lateral decubitus position for 30 mi-nutes or more, as well as the presence of at least 2 g of urinary proteinover 24 hours or a urinary dipstick value of 3+ [18].

Pre-eclampsiawas deemed tobe “stable” in the absence of visual signsor symptoms (scotomata or blurred vision), frontal and/or occipital head-ache, hyperreflexia, and either epigastric or right hypochondrium pain.

Women with eclampsia were excluded from the study, as werethose with evident hemolysis, elevated liver enzymes, and low plateletcount (HELLP) syndrome [11], pre-existing diabetes mellitus, epilepsy,renal disease, a contraindication to the use of magnesium sulfate suchas known hypersensitivity to the drug, or anuric or oliguric urinary out-put under 25 mL/hour.

All women were already receiving magnesium sulfate before andduring delivery (loading dose 6 g; maintenance dose 1 g/hour). Post-partum, all participants received a 12-hour infusion of magnesium sul-fate at 1 g/hour. Approximately 6–8 hours after delivery, eligiblewomen were invited to participate in the trial. Those who providedwritten informed consent were enrolled and assigned a randomizationnumber.

The participants were randomized 1:1 to receive an ongoing(24-hour) or abbreviated (12-hour) magnesium sulfate infusion at1 g/hour. Randomization was achieved using a sequential list ofrandom numbers ranging from 1 to 120, generated by Random Allo-cation Software version 1.0 (M. Saghaei, Isfahan University of Med-ical Sciences, Isfahan, Iran). The group allocation was concealed inopaque, sequentially numbered envelopes, which remained sealeduntil randomization.

At 12 hours, after completion of the initial period of intravenousmagnesium sulfate infusion, eachwoman’s study envelopewas opened.If she was assigned to 24 hours of treatment, her infusion was contin-ued at 1 g/hour for another 12 hours. If she was assigned to 12 hoursof treatment, her infusion was stopped.

As a safety measure, in the rare situation where a woman wasassigned to the abbreviated magnesium protocol and she had veryhigh blood pressure (systolic blood pressure of 180 mm Hg or moreand/or a diastolic blood pressure of 120mmHg ormore), her urine out-putwas under 25 mL/hour, and/or shehad signs of imminent eclampsia,shewasmaintained onmagnesium sulfate for theduration deemednec-essary by her attending physician. These women were described as“need to continue magnesium sulfate treatment after 12 hours” andwere considered to belong to the abbreviated treatment group. In the24-hour treatment group, the attending physician was also permittedto extend magnesium therapy if he/she deemed this to be necessary.

Clinical and laboratory measures were assessed in both groups untilat least 24 hours following delivery.

The womenwere evaluated every 2 hours for heart rate, respiratoryrate, blood pressure, and urine output. Deep tendon reflexes were eval-uated every 6 hours and laboratory tests to screen for the HELLP syn-drome were evaluated every 24 hours.

At approximately 24 hours after delivery, each woman’s satisfac-tionwith her care was evaluated on a scale of 1–5 (1= very satisfied,2 = satisfied, 3 = not very satisfied, 4 = dissatisfied, and 5 = verydissatisfied) [19].

The primary study outcomewas the duration of anticonvulsant ther-apy postpartum. Secondary outcomes included patient satisfaction at24 hours after delivery, clinical measures such as blood pressure, timeto return to ambulation (in hours), duration of indwelling urinarycatheter use (in hours), and time until contact with the newborn infant(in hours). Additional outcomes included eclampsia, oliguria (urine out-put b25 mL/hour), postpartum hemorrhage, urinary tract infection,thromboembolic complications, liver failure, kidney failure, disseminat-ed intravascular coagulation, cerebrovascular accident, acute pulmo-nary edema, discontinuation of magnesium treatment because ofadverse effects (heat, flushing, hypersensitivity reaction, nausea, orvomiting), and the presence of any associated complication occurringprior to the woman’s discharge from hospital.

Please cite this article as: Maia SB, et al, Abbreviated (12-hour) versusevere pre-eclampsia, Int J Gynecol Obstet (2014), http://dx.doi.org/10

The analysis was by intention to treat. The t test and the Mann–Whitney U test were used for the comparison of continuous variablesas appropriate, and the χ2 and Fisher exact tests were used for the com-parison of categorical variables. All P values were two-tailed; P b 0.05was considered statistically significant.

To compare the total durations of magnesium sulfate use and post-partum urinary catheter use and the total times between delivery andthe beginning of ambulation/themother’s contactwith her newborn in-fant, risk ratios (RR) and their 95% confidence intervals (CI) were calcu-lated asmeasures of relative risk. The numbers needed to treat (NNT) toobtain a benefit were also calculated using the Evidence-Based Calcula-tor (http://moosenose.com/EBCalculator.htm).

The analysis was conducted using Epi Info version 7 (Centers for Dis-ease Control and Prevention, Atlanta, GA, USA). The sample size was cal-culated using OpenEpi version 2.3 (www.openepi.com). Based onprevious data [15], it was assumed that themean duration ofmagnesiumsulfate treatment in the abbreviated group would be 18 ± 9 hours,whereas women in the 24-hour treatment group would receive therapyfor 24±6 hours. To detect this 6-hour difference in the duration of treat-ment with a statistical power of 80% and a two-sided P value 0.05, 50womenwere neededper group. Considering possible drop-outs, the sam-ple sizewas increased by 20%, resulting in a total of 60women per group.

3. Results

During the study period, 140 of 157 women with severe pre-eclampsia were approached, but 20 women were excluded (Fig. 1). Ofthe remaining 120 women who fulfilled the eligibility criteria, 60 wererandomized to receive magnesium sulfate for 12 hours and 60 to re-ceivemagnesium sulfate for 24 hours. During the first 12 hours of mag-nesium sulfate treatment, four women in each group were excluded.Therefore, data for 56 women were analyzed in each group.

With respect to the baseline characteristics of the women, no signif-icant differences were found between the groups (Table 1). Mostclinical and laboratory parameters at admission were similar, with nodifferences in the severity of the disease. However, the median plateletcount was lower in the 12-hour group than in the 24-hour group(178 500/mm3 vs 219 500/mm3; P = 0.01).

During the first 12 hours, no statistically significant differences werefound between the groupswith respect to blood pressure or urine output(Table 2). However, therewas a difference in themean urine output dur-ing the period of 12–24 hours following treatment initiation (12-hourgroup, 128.3 mL/hour; 24-hour group, 159.8 mL/hour; P = 0.008).

There was no difference between the two groups in the number ofwomen with episodes of very high blood pressure (Table 2). Magne-sium sulfate therapy was extended in three women in the 12-hourgroup; in the 24-hour group, there was no need to prolong the durationof therapy.

None of thewomen had to interrupt anticonvulsant therapy becauseof adverse effects of the drug or to re-initiate magnesium sulfate treat-ment following suspension of the drug. There were no occurrences ofeclampsia, acute pulmonary edema, thromboembolic complications,kidney failure, liver failure, disseminated intravascular coagulation, ce-rebrovascular accident, ormaternal death. Onewoman had oliguria andone woman had a urinary tract infection in the 12-hour group, and onewoman in the 12-hour group and twowomen in the 24-hour group hadpostpartum hemorrhage. Even when the presence of any complicationwas used as an outcome measure, no difference was found betweenthe groups. The degree of satisfaction was also similar (Table 2).

The duration of anticonvulsant therapy was significantly shorter inthe 12-hour group (12.5 hours vs 24.0 hours; P b 0.001) (Table 3),resulting in a reduction of the total dose of magnesium sulfate. Thetotal time of indwelling urinary catheter use was also significantlyshorter in the 12-hour group (14.3 hours vs 25.3 hours; P b 0.001).Overall, 98.2% of the women in the 24-hour group used an indwellingurinary catheter for more than 12 hours compared with 62.5% of the

s traditional (24-hour) postpartum magnesium sulfate therapy in.1016/j.ijgo.2014.03.024

Fig. 1. Selection and follow-up of participants (CONSORT flow chart).

Table 1Baseline characteristics among women with stable severe pre-eclampsia who received magnesium sulfate for 12 versus 24 hours after delivery.a

Characteristic 12 hours(n = 56)

24 hours(n = 56)

P value

Age, y 24.7 ± 6.3 26.3 ± 7.6 0.26Number of pregnancies 2.1 (1–3) 2.0 (1–2) 0.57Parity 1.8 (1–2.5) 1.8 (1–2) 0.73Gestational age at delivery, wk 36.8 ± 3.0 37.2 ± 4.9 0.14Route of deliveryCesarean delivery 36 (64.3) 33 (58.9) 0.28

Clinical parameters at inclusion in the studySBP, mm Hg 142.4 ± 16.4 142.1 ± 15.1 0.91DBP, mm Hg 92.4 ± 11.9 95.4 ± 10.8 0.17Heart rate, bpm 88.1 (80–94) 86.1 (80–92) 0.38Respiratory rate, breaths/min 19.0 (18–20) 18.8 (18–20) 0.60Urine output, mL/h 117.2 ± 77.6 112.5 ± 79.6 0.76

Laboratory parameters at diagnosisHematocrit, % 34.9 ± 15.1 35.3 ± 13.6 0.53Platelets, mm3 178 500 (158 000–228 500) 219 500 (176 000–268 000) 0.01Creatinine, mg/dL 0.6 ± 0.1 0.6 ± 0.1 0.63Uric acid, mg/dL 5.2 ± 1.4 5.8 ± 1.6 0.26LDH, U/l 280.0 ± 110.7 278.1 ± 97.6 0.92AST, U/l 24.0 ± 16.5 25.2 ± 16.5 0.99Total bilirubin, mg/dL 0.5 ± 0.4 0.4 ± 0.2 0.13

Abbreviations: AST, aspartate aminotransferase; DBP, diastolic blood pressure; LDH, lactate dehydrogenase; SBP, systolic blood pressure.a Values are given as mean ± SD, median (interquartile range), or number (percentage).

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Please cite this article as: Maia SB, et al, Abbreviated (12-hour) versus traditional (24-hour) postpartum magnesium sulfate therapy insevere pre-eclampsia, Int J Gynecol Obstet (2014), http://dx.doi.org/10.1016/j.ijgo.2014.03.024

Table 2Outcomes of magnesium sulfate use for 12 versus 24 hours: need to prolong treatment,clinical parameters, complications, and treatment satisfaction.a

Outcome measure 12 hours(n = 56)

24 hours(n = 56)

P value

Need to prolong treatment 3 (5.4) 0 (0.0) 0.50b

Blood pressure and urinaryoutput at 0–12 hoursHighest SBP, mm Hg 151.3 ± 15.8 152.3 ± 16.6 0.75Highest DBP, mm Hg 102.2 ± 11.3 100.7 ± 12.5 0.51Urinary output, mL/h 107.0 ± 46.7 119.7 ± 76.5 0.29

Blood pressure and urinaryoutput at 12–24 hoursHighest SBP, mm Hg 148.8 ± 15.7 151.5 ± 16.4 0.38Highest DBP, mm Hg 98.6 ± 11.4 100.3 ± 10.4 0.40Urinary output, mL/h 128.3 ± 50.9 159.8 ± 61.6 0.008

Presence of very high blood pressureepisodes (0–24 hours)c

12 (21.4) 12 (21.4) N0.99

Complicationsd

Urinary tract infection 1 (1.8) 0 (0.0) 0.50b

Oliguria 1 (1.8) 0 (0.0) 0.50b

Postpartum hemorrhage 1 (1.8) 2 (3.6) 0.50b

Any complication 13 (23.3) 15 (26.8) 0.66SatisfactionVery satisfied or satisfied 41 (73.2) 36 (64.3) 0.30

Abbreviations: CI, confidence interval; DBP, diastolic blood pressure; RR, relative risk; SBP,systolic blood pressure.

a Values are given as mean ± SD or number (percentage).b Fisher exact test.c “Very high blood pressure” defined as systolic blood pressure of 180 mm Hg or more

and/or a diastolic blood pressure of 120 mm Hg or more.d Participants may have had more than one complication.

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women in the 12-hour group, reflecting a significant reduction in its use(RR, 0.63; 95% CI, 0.51–0.78;NNT=3). Similar resultswere obtained forthe time from delivery to ambulation (18.8 hours vs 25.8 hours in the12-hour and 24-hour groups, respectively; P b 0.001) (Table 3).

A reduction in the time between delivery and contact with the new-born infant was found (29.6 vs 35.0 hours in the 12-hour and 24-hourgroups; P = 0.03). In the abbreviated treatment group, there was a38% reduction in the risk of late (after 24 hours of delivery) contactwith the neonate (NNT = 3) (Table 3).

4. Discussion

In women with stable severe pre-eclampsia, a shorter duration ofmagnesium sulfate therapy was associated with less exposure to thedrug, both in terms of treatment duration and in terms of total dose,and the clinical outcomes were similar to those among women whohad received the traditionally recommended 24-hour regimen of mag-nesium sulfate therapy.

The shorter regimenwas found to be safe for this particular group ofwomen, although the study did not have sufficient power to evaluatethe frequency of eclampsia. However, in a systematic review onmagne-sium sulfate for the prevention of eclampsia available in the Cochrane

Table 3Outcomes of magnesium sulfate use for 12 versus 24 hours: total duration of magnesium sunewborn.a

Outcome measure 12 hours (n =

Total duration of magnesium sulfate use, h 12.5 ± 2.3Total duration of postpartum use of an indwelling urinary catheter, h 14.3 ± 3.7Postpartum use of an indwelling urinary catheter for N12 hours 35 (62.5)Time from delivery to beginning of ambulation, h 18.8 ± 4.9Time from delivery to beginning of ambulation N15 hours 36 (64.3)Time from delivery to contact with newborn, hb 29.6 ± 14.0Time from delivery to contact with newborn N24 hoursb 30 (55.6)

Abbreviations: CI, confidence interval; NNT, number needed to treat; RR, relative risk.a Values are given as mean ± SD or number (percentage).b Time until contact with the newborn infant was not evaluated in one woman in the 24-ho

neonatal death).

Please cite this article as: Maia SB, et al, Abbreviated (12-hour) versusevere pre-eclampsia, Int J Gynecol Obstet (2014), http://dx.doi.org/10

Library [9], convulsions occurred in only 1.45% of women with pre-eclampsia receivingmagnesium sulfate; therefore, to determine any dif-ference in the frequency of eclampsia with the shorter regimen, a sam-ple of approximately 18 000womenwould have been required. Perhapsa future meta-analysis of randomized clinical trials will have sufficientpower to determine whether there is any difference in the incidenceof eclampsia.

Previous nonrandomized studies [14,15] used clinical parameters(for example absence of symptoms of the imminence of eclampsia, re-establishment of diuresis) as criteria for interruptingmagnesium sulfateuse in postpartum women with pre-eclampsia, with the result that asignificant reduction in the duration of treatment was achieved.

In a randomized clinical trial [20] comparing an abbreviated 6-hourmagnesium sulfate regimen versus 24-hour treatment in postpartumwomenwith pre-eclampsia considered to be at a low risk for eclampsia,only one woman in the 6-hour magnesium sulfate group needed to re-initiate therapy because of worsening hypertension nine hours follow-ing delivery.

In another study [21] comparing 12-hour versus 24-hour magne-sium sulfate therapy in postpartum women with mild pre-eclampsia,clinical conditions such as chronic hypertension and type I diabeteswere also found to be factors that would increase the risk of aggravatingthe condition, requiring postpartum anticonvulsant therapy to beextended.

Another randomized clinical trial [22] that used the evaluation ofurine output as the criterion for interruptingmagnesium sulfate therapyin postpartum women with severe pre-eclampsia reported results sim-ilar to those found in the present study, in particular a reduction in theduration of treatment.

Themean urine output during the period of 12–24 hours after deliv-ery was approximately 30 mL/hour higher when magnesium sulfatetherapy was used for 24 hours compared with the shorter treatmentduration. The higher level of diuresis found in the 24-hour group maybe attributable to the longer duration of treatment and the volume offluid administered together with the anticonvulsant.

A significant reduction was found in the duration of postpartum in-dwelling urinary catheter use, which may account for the reduction inthe risk of urinary tract infection [23] and the decrease in postpartumdiscomfort reported by the women; these outcomes remain to be eval-uated in future studies.

A reduction was found in the time to ambulation with the shorterregimen of postpartum magnesium sulfate. Early ambulation is impor-tant for the prophylaxis of deep vein thrombosis [24]. The shorter, 12-hour magnesium sulfate therapy enables women to benefit from thisprophylactic practice.

Another benefit associated with shorter magnesium sulfate therapywas the possibility of earlier contact with the newborn, improving thelikelihood of establishing breastfeeding. It is common practice duringmagnesium sulfate administration for the woman to remain in an inter-mediate or intensive care unit, whichmay contribute toward keeping themother apart from her infant, with all resulting disadvantages. In the

lfate use, duration of catheterization, time to ambulation, and time to contact with the

56) 24 hours (n = 56) RR (95% CI) P value NNT

24.0 ± 3.6 — b0.001 -25.3 ± 3.5 — b0.001 -55 (98.2) 0.63 (0.51–0.78) b0.001 325.8 ± 6.9 — b0.001 —

51 (91.1) 0.57 (0.42–0.77) b0.001 335.0 ± 10.6 — 0.03 —

49 (89.1) 0.62 (0.48–0.80) b0.001 3

ur group (stillbirth) and in two women in the 12-hour group (one stillbirth and one early

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present study, a significant reduction was found in the time from deliv-ery until contact with the newborn in the 12-hour group. We believethat this difference would have been greater if these women had beendischarged from the intensive care unit to a rooming-in environment im-mediately after discontinuation of the anticonvulsant medication. How-ever, because the abbreviated therapy protocol represented a changefrom the routine management protocol at the study institution, the par-ticipants were kept in intensive care for safety and ethical reasons, toguaranteemore rigorous surveillance for at least 24 hours. In a systemat-ic review [16], postpartum hospital stay was not evaluated because thedata (obtained from only three clinical trials) were heterogeneous.

As a future perspective, shortermagnesium sulfate therapymayper-mit the mother to be released earlier from intensive care, freeing uphospital beds. The available beds would benefit other postpartumwomen with more severe clinical conditions, and there would also bea reduction in the total time of postpartum hospitalization. Althoughfurther studies are indispensable before this practice can be incorporat-ed, there is evidence of real benefits, both for the users and for the publichealthcare system, which would translate into savings on the costs ofimprovements in tertiary care.

It should be emphasized that postpartum women with other moresevere hypertensive syndromes (exacerbation of chronic hypertension,HELLP syndrome, eclampsia) and those with associated clinical condi-tions were excluded from the present study, and the available evidencein relation to the shorter regimen ofmagnesium sulfate therapy in thesewoman is incipient and sparse. Therefore, we do not recommend earlydiscontinuation of postpartum anticonvulsant therapy in this group ofwomen. Moreover, well-designed studies should be conducted withlarger sample sizes to avoid hasty conclusions based on a single study.

In conclusion, in ideal conditions (when the surveillance of postpar-tum women can be guaranteed), women with stable severe pre-eclampsia can be re-evaluated clinically and through laboratory testsafter 12 hours of postpartum magnesium sulfate use and the magne-sium sulfate infusion can be stopped, allowing other possible benefitsderived from this practice.

Conflict of interest

The authors have no conflicts of interest.

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